Novel blood test detects early colorectal cancers, precancerous polyps
A blood test called Nu.Q detected 80% of stage 1 colorectal cancers and 66% of precancerous polyps in an asymptomatic screening study in Denmark, according to interim results reported by the developer, VolitionRx.
The company plans on advancing the product through two further studies and hopes to receive a CE marking in 2018. They are also working to bring the test to market in the United States, according to the press release.
The tests are based on what the company calls “nucleosomics,” or the practice of measuring nucleosomes in blood or other bodily fluids.
“Our tests use only a small amount of blood and could be added to routine blood screening regimens at a reasonable cost,” Cameron Reynolds, CEO of VolitionRx, said in the press release. “We believe that with further development, our Nu.Q panel could form the basis of new colorectal cancer tests with early stage disease detection, and that our tests could become accessible to and usable by a wide section of the screening population around the world.”
Researchers analyzed the test in a study of 680 patients in Denmark. In the study, the researchers evaluated the results of the patients’ blood samples using a small panel of three ELISA assays and considered their age and smoking histories. This was able to detect 80% of stage 1 colorectal cancer (CRC) cases and 66% of precancerous, high-risk adenomas at 78% specificity, according to the press release.
VolitionRx plans to continue ramping up trials for the blood test this year. The next study, scheduled to begin in the second quarter of 2018, will include 4,300 participants and will help determine which assays to use in the final test panel, which the company expects will include five to six assays. VolitionRx will use data from that trial to support a double-blind validation study involving more than 12,000 participants, set to commence in the second half of 2018, according to the press release.
In the U.S., VolitionRx is also collaborating with the National Cancer Institute’s Early Detection Research Network for a CRC screening study of a cohort that includes more than 13,500 participants. Researchers expect to complete data collection for the study by 2020, according to the press release.
The company also plans to evaluate Nu.Q assays in other prevalent cancers.
Disclosures: Reynolds is employed by VolitionRx.